Regulatory & Reimbursement
FDA Output April 2024
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2024. Updated April 18, 2024.
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Pathways' Document Depot
Pathways Document Depot: Cataloging Medtech Policy
A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
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Pathways' Picks
Reliance in Brazil, Manufacturing in China, Reprocessing in the EU, and More
In this week’s Pathways Picks: Brazil issues regulatory reliance policy to streamline premarket reviews; China details contract manufacturer controls; EU issues update on single-use device reprocessing; US policymakers discuss telehealth reimbursement and broader physician Medicare issues. And from the FDA: Commissioner Califf testifies on Capitol Hill; CDRH seeks panelist nominations; and Philips consent decree finalized.